Current Good Manufacturing Practice (cGMP) regulation guarantees the safety of microbial fermentation process with critical requirements. With years of experience in microbial fermentation development, Creative Biogene is dedicated to provide customized microbial cGMP fermentation services to meet different needs.
Creative Biogene's integrated microbial fermentation platform consists of dedicated process development systems, large-scale facilities and quality control technology. The Current Good Manufacturing Practice (cGMP) is a latest system designed to minimize the contamination risk from raw materials, environment and equipment to the training of staffs. It also avoids the production of unwanted by-products.
• Creative Biogene's cGMP Fermentation Capability
Creative Biogene puts the quality of products in the first place and has maintained various quality management systems. Our staffs show respect to standard procedures and are in advanced training for cGMP standard regulations. Parts of our cGMP fermentation capability are followed.
• cGMP cell line banking with dedicated facility
• cGMP manufacturing from pre-clinical to commercial scale
• Stainless steel or single-use fermentation systems
• Batch and fed-batch fermentation for high density cell culture
• Validated cGMP computer system such as visual programming control
• Ensuring written procedures that cover sampling, identification, storage, handling, testing, and documentation of test results
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• Microbial cGMP Fermentation Services
• Microbial Process Development and Scale-up
Yeast and microbial organism fermentation consume large amounts of nutrients and require complicated downstream processing, leaving biomanufacturing processes heavy endeavors. To address these obstacles, Creative Biogene is dedicated to develop the fermentation process to achieve time and cost-efficiency. We have expertise at the following items.
• Strain development and cell banking
• Microbial fermentation of different scales
• Downstream extraction, centrifugation, cell disruption, purification
• Qualified filling and packaging
• Advanced software programs and quality control systems
All items of the above are compliant with cGMP standards.
• Choose Microiosci as Your Reliable Partner
Quality control technology is not enough to prevent the whole microbial fermentation process from contamination and unwanted by-products formation while a qualified cGMP system provides comprehensive guidelines regarding the raw materials preparation to final products validation, making the manufacturing process reliable and the products be accredited by authority agencies.
Creative Biogene provides expert cGMP manufacturing using E.coli and yeasts. Our upscaling and manufacturing of customers' biotherapeutic products are compliant with the cGMP standards.
As one of the reliable partners in microbial cGMP fermentation, Creative Biogene is known for the good track records and professional team. We offer in-house and partnered microbial cGMP fermentation services and we are available to address any problems you may have on biomanufacturing. Contact us for more details and let's tailor your own plan.